FDA Publishes First Annual Report on Antibiotics Sold or Distributed for Use in Food-Producing Animals

The Animal Drug User Fee Amendments of 2008 (“ADUFA”) directs FDA to prepare annual summaries of antimicrobials sold or distributed for use in food-producing animals. The data are derived from information sponsors of new animal drug applications provide to FDA (as required by Sectin 105 of ADUFA). Last week, FDA published its first annual report summarizing the data. The report shows that approximately 29 million pounds of antibiotics for use in food-producing animals were sold in 2009. More than 9 million pounds of the antibiotics were tetracyclines. The report does not include anti-fungal or anti-viral drugs because, with the exception of formalin and hydrogen peroxide water immersion products, no approved anti-fungal or anti-viral products for use in food-producing animals were marketed in 2009.

The data on antimicrobial drugs sales and distribution information are intended to assist FDA in the Agency’s evaluation of antimicrobial resistance trends as well as FDA’s analysis of other issues that may arise relating to the safety and effectiveness of antimicrobial drugs approved for use in food-producing animals. Because this is the first report, meaningful trend analysis are not yet possible.